(34 days)
Not Found
No
The document mentions "automatically determine bladder volume" and "Automated bladder volume measurements are supported," but it does not explicitly mention AI, ML, or any related technologies like deep learning or neural networks. The description of the device and performance studies focuses on standard ultrasound technology and image processing, not advanced AI/ML algorithms.
No.
The device is used for non-invasive imaging and diagnostic purposes, not for treating conditions.
Yes
The "Device Description" explicitly states that the "Signostics Ltd SpecT system is a hand-held, diagnostic ultrasound system." It also mentions its purpose is to "acquire ultrasound echo data and display it," and that "Automated bladder volume measurements are supported," all of which are diagnostic functions.
No
The device description explicitly states it is a "hand-held, diagnostic ultrasound system" and mentions acquiring "ultrasound echo data," which indicates the presence of hardware components beyond just software.
Based on the provided information, the SpeqT device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- SpeqT Function: The SpeqT is a diagnostic ultrasound system that performs non-invasive imaging of the human body. It acquires ultrasound echo data and displays it as images. It also performs automated bladder volume measurements based on these images.
- No Specimen Analysis: The description of the SpeqT's function does not involve the analysis of any specimens taken from the body. It directly interacts with the body using ultrasound waves.
Therefore, the SpeqT falls under the category of in vivo diagnostic imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The SpeqT is for non-invasive imaging of the human body and is intended for the following applications: Abdominal, Musculoskeletal, Pediatric, and Small Organ. Users must have ultrasound training for abdominal, musculoskeletal, pediatric, and small organ imaging.
The SpeqT can also be used to obtain an image of the bladder that is used to automatically determine bladder volume.
The SpeqT is for non-invasive imaging of the human body and is intended for the following applications: Abdominal, Musculoskeletal, Pediatric, and Small Organ. Users must have ultrasound training for abdominal, musculoskeletal, pediatric, and small organ imaging.
The SpeqT can also be used to obtain an image of the bladder that is used to automatically determine bladder volume.
Product codes (comma separated list FDA assigned to the subject device)
IYO, ITX
Device Description
The Signostics Ltd SpecT system is a hand-held, diagnostic ultrasound system with an on-screen display. Its purpose is to acquire ultrasound echo data and display it in B-Mode, on an off-the-shelf display. Automated bladder volume measurements are supported.
Mentions image processing
All systems transmit ultrasonic energy into patients, then process received echoes to generate images of anatomy and perform measurements.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic pulsed echo imaging system
Anatomical Site
Abdominal, Musculoskeletal, Pediatric, Small Organ (prostate), Bladder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Users must have ultrasound training for abdominal, musculoskeletal, pediatric, and small organ imaging.
Lumify is intended for use in environments where healthcare is provided by healthcare professionals, with the exception of home, ambulance, and air.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing has shown substantially equivalent imaging performance, and there is no evidence of adverse events due to either of these predicate systems. The second part of the intended use statement is substantially equivalent to the Verathon BVI 9400 system, and internal clinical performance testing comparing the SpegT and Verathon BVI 9400 shows the SpeqT to be equivalent or better performance than the Verathon BVI 9400.
The new SpeqT has been bench tested for imaging performance and measurement accuracy, with tests showing the SpeqT imaging performance and measurement accuracy to be substantially equivalent to the SpeqRT and Speq predicate devices.
The conclusion from the testing is the device is safe and effective for its intended use, and performs as well or better than the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K130659, K090505, K152899, K071217
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 21, 2016
Signostics Limited % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, NW BUFFALO MN 55313
Re: K160420
Trade/Device Name: SpeqT Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: February 12, 2016 Received: February 16, 2016
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D.'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
SpeqT
Indications for Use (Describe)
The SpeqT is for non-invasive imaging of the human body and is intended for the following applications: Abdominal, Musculoskeletal, Pediatric, and Small Organ. Users must have ultrasound training for abdominal, musculoskeletal, pediatric, and small organ imaging.
The SpeqT can also be used to obtain an image of the bladder that is used to automatically determine bladder volume. See the attached Indications for Use form for specific imaging modes and applications.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.
3
Indications for Use
| 510(k) Number (if known) | K160420 |
|---|---|
| Device Name | SpeqT |
510(k) Indications for Use Form
TABLE 1 - SPEQT INDICATIONS FOR USE FORM
System: SpeqT Intended Use: Diagnostic ultrasound imaging of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track I Only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined | ||||||||
| (Specify) | Other* | ||||||||
| (Specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | N | ||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | ||||||||
| Small Organ (Specify)* | N | ||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging | |||||||||
| & Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | N | ||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (Specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
*Small organ imaging is prostate
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Indications for Use
| 510(k) Number (if known) | K160420 |
|---|---|
| Device Name | SpeqT |
TABLE 2 - SPEQT INDICATIONS FOR USE FORM
| System: | SpeqT |
|---|---|
| Transducer: | B3-5 (P04200) |
| Intended Use: | Diagnostic ultrasound imaging of the human body as follows: |
| Clinical Application | Mode of Operation |
|---|---|
| General (Track I Only) | Specific (Tracks I & III) |
| B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) | ||
|---|---|---|---|---|---|---|---|---|
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | N | |||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | |||||||
| Small Organ (Specify) | N | |||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging & Other | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal (Conventional) | N | |||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
*Small organ imaging is prostate
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
5
510(k) Summary
-
- Sponsor: Signostics Ltd PO Box 1048, Pasadena 1284 South Road Clovelly Park, SA 5042 Australia
-
- Contact Person: Stewart Bartlett Chief Operating Officer Telephone: +61 (8) 7424 0600
-
- Date Prepared: January 22, 2016
-
- Device Name : SpeqT
-
- Proprietary/Marketed Names: Uscan
6. Common/Usual Name:
Diagnostic ultrasound system
7. Classification
Regulatory Class: II
Review Category: Tier II
Ultrasonic Pulsed Echo Imaging System
Diagnostic Ultrasound Transducer
(21 CFR 892.1560, 90-IYO)
(21 CFR 892.1570, 90-ITX)
Classification Panel: Radiology
8. Predicate Devices
SpeqRT Ultrasound System (K130659).
Speq Ultrasound System (K090505).
Philips Lumify Diagnostic Ultrasound System (K152899)
Verathon BVI9400 bladder scanner (K071217)
6
9. Risk Analysis Method Used
Signostics Ltd applied ISO-14971 to the design and development of the SpeqT. The conclusion from the risk analysis was the device was safe for its intended use and does not pose any unacceptable risks.
10. Basis for Substantial Equivalence
Signostics Ltd believes the SpeqT system described in this Submission is substantially equivalent to the predicate devices as follows:
- a. SpeqRT Ultrasound System (K130659).
- b. Speq Ultrasound System (K090505).
- c. Philips Lumify Diagnostic Ultrasound System (K152899)
- Verathon BVI 9400 bladder scanner (K071217) d.
All systems transmit ultrasonic energy into patients, then process received echoes to generate images of anatomy and perform measurements. The SpeqT system is substantially equivalent to the SpeqRT Ultrasound System, Speq Ultrasound System, and Lumify Diagnostic Ultrasound System as they allow for the display of real-time Bmode imaging. The SpeqT system is also substantially equivalent to the Verathon BVI 9400 as both allow automatic measurement of volume of urine in a bladder. The Verathon BVI 9400 only displays an image if the measurement is printed.
| Transducer | Signostics
SpeqT | Signostics
SpeqRT
S3-5 (K130659) | Signostics
Signos (K090505) | Philips Lumify
(K152899) | Verathon BVI
9400 (K071217) |
|---------------------------|------------------------------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Type | Sector | Sector | Sector | Electronic array | Sector |
| Geometry | Annular | Annular | Annular | Curved linear array
Linear array | Annular |
| Intended Uses | Adominal,
Pediatric,
Musculoskeletal,
Small Organ | Adominal, Fetal,
Pediatric, Cardiac,
Peripheral Vessel,
Musculoskeletal | Adominal, Fetal,
Pediatric, Cardiac,
Peripheral Vessel,
Musculoskeletal | Adominal, Fetal,
Pediatric, Cardiac,
Cardiac Fetal,
Gynecology,
Peripheral Vessel,
Musculoskeletal,
Small Organ,
Urology | Adominal, Fetal,
Pediatric, Cardiac,
Peripheral Vessel,
Musculoskeletal |
| Centre Frequency | 3.5MHz | 3.5MHz | 3.5MHz/7.5MHz | 3.5MHz/8.0MHz | 3.0MHz/1.74MHz |
| Element Outer
Diameter | 15mm | 15mm | 12mm/5.6mm | NA | 13mm |
| Number Elements | 8 | 8 | 1 | Unknown | 1 |
| Acoustic Output | | | | | |
| Max Ispta.3
(mW/cm²) | 5.69 | 162 | 26 | Unknown | 5 |
| Max MI | 0.823 | 0.679 | 0.56 | Unknown | 0.95 |
| Max TIS | 0.0903 | 0.160 | 0.05 | Unknown | Unknown |
The SpeqT Ultrasound System is substantialy equivalent to the predicates as follows:
7
The SpeqT system is a general ultrasound imaging device with automated bladder measurement functionality, and is intended for abdominal (including the bladder), pediatric (including the bladder), and small organ (prostate) scanning.
The SpeqT probe and transducer are almost identical in construction, materials (including patient contact materials), and design, to the SignosRT Personal Ultrasound probe and transducer (K130659). The differences are: the indications for use statement; the transducer field of view (120° for SpeqT versus 90° for SignosRT); and the display (Android off-the-shelf tablet for SpecT versus custom Windows CE tablet for SignosRT). The transducer operating frequency (3.5MHz) is also identical. Both systems contain sector transducers with annular (circular) acoustic elements generating pie shaped images, have identical operating frequency, identical outer diameter of acoustic crystal, identical acoustic output in B-mode, and both maintain MI and TI to be 3.5V, >3950mAh) Probe (>3.5V, 1350mAh) |
Technical specifications for the Signostics SpeqT system are as follows:
9
| Leakage Current: | IEC 60601-1 3rd Edition Compliant |
|---|---|
| Primary Breakdown Voltage: | 3000VAC |
| Safety Standards: | IEC 60601-1:2005, ES60601-1:2005, EN 60601-1:2006, IEC 60601-2- |
| 37:2007, IEC 60601-1-2:2007, ISO 10993-1:2009, ISO-10993-5:2009, | |
| ISO 10993-10:2002, ISO 10993-10:2010, ISO 10993-12:2007 | |
| Protection Class: | Class II: per IEC 60601-1 |
| Degree of Protection: | Type BF: per IEC 60601-1 |
| Environmental | ||
|---|---|---|
| Mechanical Shock : | Drop and push testing per IEC60601-1 | |
| Mechanical Vibration: | Random Acceleration Profile per JIS Z 0232:2004 5Hz-300Hz | |
| Drop Test (to concrete): | 1 meter | |
| Operating Temperature: | 5 to 40 C | |
| Humidity: | 15 to 90% RH, non-condensing | |
| Water Resistance: | Transducer IPX1 degree of protection against water | |
| Altitude: | 70kPa – 101.5kPa (0.7 – 1.015 standard atmospheres) (2500m or 8200 feet) operating | |
| Storage | ||
| Temperature: | -20 to 50 C | |
| Humidity: | 10 to 93% RH, non-condensing | |
| Pressure: | 50kPa – 101.5kPa (0.5 – 1.015 standard atmospheres) |
Non-clinical Performance Data 12.
Signostics Ltd is applying FDA recognised standards as detailed in the tables above to evaluate the safety of the SpeqT.
The new SpeqT has been bench tested for imaging performance and measurement accuracy, with tests showing the SpeqT imaging performance and measurement accuracy to be substantially equivalent to the SpeqRT and Speq predicate devices.
The SpeqT has been tested by independent laboratories to IEC 60601-1:2005, IEC 60601-2-37:2007, IEC 60601-1-2:2007, ISO 10993-5:2009, ISO 10993-10:2002, ISO 10993-10:2010, ISO 10993-12:2007, NEMA UD-2-2004 (R2009), NEMA UD-3-2004(R2009) and found to comply with all standards.
The software and firmware in the SpeqT has been developed and verified according to IEC 62304:2006. The verification report (Appendix R), traceability (Appendix Q), and risk analysis (Appendix A) demonstrate the SpeqT operates as intended and risks mitigated in firmware have been verified.
The conclusion from the testing is the device is safe and effective for its intended use, and performs as well or better than the predicate devices.